Combination of Cetuximab and NK Immunotherapy for Recurrent Non-small Cell Lung Cancer

NCT02845856 | Completed Phase 1

• 1 other identifier: NK-Cetuximab
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is the safety and efficacy of Cetuximab plus natural killer(NK) immunotherapy to recurrent non-small cell lung cancer with EGFR mutation.

Conditions

Recurrent Non-small Cell Lung Cancer

Keywords

recurrent lung cancer; EGFR mutation; Cetuximab; NK immunotherapy

Outcome Measures

Primary Outcomes (1)

• Relief degree evaluated by RECIST

  It will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)

  3 months

Secondary Outcomes (2)

• Progress free survival (PFS)

  1 year

• Overall survival (OS)

  3 years

Study Arms (2)

Cetuximab and NK immunotherapy

EXPERIMENTAL

In this group, the patients who have EGFR mutation of lung cancer will receive regular Cetuximab treatment accompanied with multiple NK immunotherapy. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Drug: Cetuximab; Biological: NK immunotherapy

Cetuximab

ACTIVE COMPARATOR

In this group, the patients who have EGFR mutation of lung cancer will receive regular Cetuximab to decrease tumor burden. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Drug: Cetuximab

Interventions

Cetuximab DRUG

400 mg/m2 IV over 120 minutes on day 1 of cycle 1 only, and 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations

Also known as: Erbitux, C225

Cetuximab; Cetuximab and NK immunotherapy

NK immunotherapy BIOLOGICAL

For each procedure, 10 billion cells will be infused in 4 times

Cetuximab and NK immunotherapy

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
• Body tumor 1-6, the maximum tumor length \< 5 cm
• KPS ≥ 70, lifespan \> 6 months
• Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

You may not qualify if:

• Patients with cardiac pacemaker
• Patients with brain metastasis
• Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead
• Shenzhen Hank Bioengineering Institute: collaborator

Study Sites (1)

Fuda cancer institute in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jibing Chen, MD, PhD

  Fuda Cancer Hospital, Guangzhou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: July 27, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2019
• Last Updated: September 12, 2019

Record last verified: 2018-07

Locations

CN (1)